Dental Whitening Compositions

ABSTRACT

A two-component whitening system has a de-sensitizing effect as well as re-mineralizing capability. The system may be an unfoamed, a foamed or a foamable composition. The system has a first component with at least one peroxide compound, at least one source of phosphate and at least one gelling agent; and a second component with at least one source of calcium, strontium and/or mixtures thereof. The second component may also contain at least one gelling agent, and the composition maybe present as a foam or is foamable. The composition may be packed in a two-compartment syringe.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional patentapplications Ser. No. 60/626,407,filed Nov. 9, 2004, entitled “ToothWhitening Compositions”; 60/631,121, filed Nov. 26, 2004, entitled“Whitening System”; 60/643,309, filed Jan. 22, 2005 entitled “DentalWhitening”; and 60/653,421, filed Feb. 15, 2005, entitled “WhiteningSystem Capable of Effective Whitening Action”; the contents of which arehereby incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to improvements in tooth treatmentcompositions. In particular, this invention relates to whiteningcompositions.

BACKGROUND OF THE INVENTION

A tooth is comprised of an inner dentin layer and an outer hard enamelthat is coated with a protective layer called the acquired pellicle. Theenamel layer is composed of hydroxyapatite crystals that create asomewhat porous surface. The pellicle or the enamel can become stainedor discolored. It is believed that the porous nature of the enamel layeris what allows staining agents and discoloring substances to permeatethe enamel and discolor the tooth.

Many substances that a person's teeth confront or come in contact withon a daily basis can “stain” or reduce the “whiteness” of one's teeth.In particular, food products, tobacco products and fluids such as teaand coffee that one consumes tend to stain one's teeth. These stainingand discoloring substances can then permeate the enamel and causenoticeable discoloration of one's teeth. At the same time, some of thefood and drinks can cause de-mineralization of the teeth.

One solution to the staining problem is through tooth bleaching. Somedentifrices, like toothpastes, gels, and powders, contain active oxygenor hydrogen peroxide liberating bleaching agents including peroxides,percarbonates and perborates of the alkali and alkaline earth metals orcomplex compounds containing hydrogen peroxide.

The amount of whitening obtained during tooth bleaching is dependentupon (1) the length of time each day the tray is worn; (2) the number ofdays the tray is worn; (3) the susceptibility of the teeth to thebleaching agent and (4) the concentration of active peroxides. Formaximum whitening, an accelerated treatment time of approximately 18-20hours per day is recommended.

One concern with some bleaching compositions is that prolonged treatmentwith highly concentrated bleaching agents present in the composition maycontribute to tooth sensitivity following treatment. Even treatmentswith compositions not known to increase tooth sensitivity in mostpatients might still cause sensitivity in patients more prone to suchsensitivity tendencies.

Another concern is that aggressive brushing, or any treatment with lowerpH whitening compositions, as noted in Price et al. (The pH ofTooth-Whitening Products, J Can Dent Assoc, 66:421-6, 2000), may alsolead to further de-mineralization of the tooth, decreasing its hardness.

Many attempts have been made to provide dentinal sensitivity relief,sometimes in a separate system from the bleaching system. Other attemptshave been made to use a single system to attack both problems. At thesame time, attempts have been made to re-mineralize the tooth, again inseparate systems.

Therefore, there remains a need for a one-system approach to solving allthe above mentioned problems and/or potential problems confronting thetooth.

SUMMARY OF THE INVENTION

The present invention relates to a one-system approach to whitening,sensitivity relief and re-mineralization.

The system may be a 2-component treatment composition having a firstcomponent including at least one peroxide compound, at least one sourceof phosphate and at least one gelling agent; and a second componentincluding at least one source of calcium, strontium and/or mixturesthereof, and at least one gelling agent.

In one embodiment, the system may be a foamable composition.

In another embodiment, the first component may also contain ade-sensitizing agent.

The system also includes a 2-component foamed composition having a firstcomponent including at least one peroxide compound, at least one sourceof phosphate and at least one gelling agent; and a second componentincluding at least one source of calcium, strontium and/or mixturesthereof.

The system further includes a 2-component foamable composition having afirst component including at least one peroxide compound, at least onesource of phosphate and at least one gelling agent; and a secondcomponent including at least one source of calcium, strontium and/ormixtures thereof, and at least one foaming agent.

In one embodiment of the invention, the second component may include atleast one source of peroxide.

In another embodiment of the invention, the second component may includea de-sensitizing agent.

In yet another embodiment of the invention, both components may includea de-sensitizing agent.

In a further embodiment of the invention, the first component may alsoinclude a gel stabilizer.

In yet a further embodiment of the invention, the first component may besubstantially milky, cloudy, opaque or colored, and the second componentmay be substantially clear, and vice versa; or both components may besubstantially milky, cloudy, opaque or colored.

In still another embodiment of the invention, the two-components of thesystem are adapted to be admixed and applied to the teeth from a dentaltray for sustained contact.

In yet still a further embodiment of the invention, the foamable systemmay form a long lasting, collapsible foam having a half life of at leastabout 1 hour.

In still yet another embodiment of the invention, the foamed system maybe a long lasting, collapsible foam having a half life of at least abouta month.

In other embodiments of the invention, the two components of the systemmay be provided in a two barrel syringe. In one aspect, the syringe maybe provided with a dispensing tip. In another aspect, the dispensing tipmay be adapted for foaming. In a further aspect, the tip may include amixer.

In still other embodiment of the invention, the two components of thesystem may be provided in a container having separate compartments forthe components. In one aspect, the container may be provided with adispensing pump.

The present invention further relates to a system approach for whiteningand remineralizing. In one embodiment, the system may include a lowperoxide content whitening composition having remineralizing effect. Inanother embodiment, the system may include a low peroxide contentwhitening composition having remineralizing effect with sensitivityrelief. In yet another embodiment, the system may include a low peroxidecontent whitening composition having remineralizing effect and fluoridetreatment. In a further embodiment, the system may include a lowperoxide content whitening composition having remineralizing effect,fluoride treatment and anti-bacterial effect. In others embodiments, anyof the combination effects desired may be achieved. In even moreembodiments, other agents, including anti-plaque agents, anti-stainingagents, vitamin supplements or others that may be beneficial to teeth,breath or even general health care may be included.

The present invention together with the above and other advantages maybest be understood from the following detailed description of theexemplary embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description set forth below is intended as a description ofthe presently exemplified dental whitening compositions provided inaccordance with aspects of the present invention and is not intended torepresent the only forms in which the present invention may be preparedor utilized. The description sets forth the features and the steps forpreparing and using the dental whitening compositions of the presentinvention. It is to be understood, however, that the same or equivalentfunctions and ingredients incorporated in the dental whiteningcompositions may be accomplished by different embodiments that are alsointended to be encompassed within the spirit and scope of the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which this invention belongs. Although any methods, devicesand materials similar or equivalent to those described herein may beused in the practice or testing of the invention, the exemplifiedmethods, devices and materials are now described.

All publications mentioned herein are incorporated herein by referencefor the purposes of describing and disclosing, for example, thecompositions and methodologies that are described in the publicationswhich might be used in connection with the presently describedinvention. The publications listed or discussed above, below andthroughout the text are provided solely for their disclosure prior tothe filing date of the present application. Nothing herein is to beconstrued as an admission that the inventors are not entitled toantedate such disclosures by virtue of prior invention.

The bleaching compositions of this invention includes a two-componentsystem, at least one of the components include at least one peroxidecompound.

The peroxide containing component may include, for example, metal ionfree peroxide compounds. Examples of suitable metal ion free peroxidecompounds include hydrogen peroxide and organic peroxides including ureaperoxide (carbamide peroxide), glyceryl peroxide, benzoyl peroxide andthe like. More for example, peroxides include hydrogen peroxide,carbamide peroxide and mixtures thereof. The total peroxide present inthe whitening gel ranges, for example, from about 0.5% by weight toabout 45% by weight of the gel, more for example, from about 1% byweight to about 35% by weight of the gel.

When hydrogen peroxide is used, it is usually provided as a 50% aqueoussolution. When used alone, the amount of the hydrogen peroxide aqueoussolution in the peroxide gel ranges for example, from about 1% to about60% (0.5% to 30% in the absence of water); more for example, the amountranges from about 2% to about 40% (1% to 20% in the absence of water).

On the other hand, when carbamide peroxide is used, it is likely to beused in combination with hydrogen peroxide, though it may be used alone.

When used in combination, the carbamide peroxide is generally present,for example, in an amount from about 0% by weight to about 40% byweight, and more for example, in an amount from about 0.5% to about 35%by weight. At the same time, hydrogen peroxide, for example, is providedas a 50% aqueous solution and is generally present in an amount of fromabout 0.5% to about 30% (0.25% to 15% in the absence of water); more forexample, in an amount of about 1% to about 30% (0.5% to 15% in theabsence of water).

The peroxide source may be present in either one or both components ofthe system. When it is also present in the second component, thecombined total source of peroxide content is in the same range as isdisclosed above.

The composition of the present invention may be an unfoamed, foamed orfoamable composition. In general, a foamed composition may include thesame or higher peroxide concentration as that present in an unfoamedcomposition. On the other hand, a foamable composition may include ahigher peroxide concentration in the unfoamed state so that theconcentration of peroxide after foaming may be the same or higher thanthe level present in a typical gel. For foamable compositions, theamounts of peroxide noted above may represent those in the foamed state.

For an unfoamed gel system, additional components may be added to form astable gel. These may include gelling agents, gel stabilizers,humectants, and other adjuvants for improving gel consistency, may beadded to one or both components.

Gelling agents which may be used in the preparation of whitening gelsinclude, for example, cellulosic gums, fumed silica, for example,CAB-O-SIL fumed silica provided by Cabot Corporation, and emulsifyingwaxes such as Polawax (emulsifying wax NF) or Crodafos CES (cetearylalcohol (and) dicetyl phosphate (and) ceteth-10 phosphate), provided byCroda, Inc., and mixtures thereof, in amounts to provide a stable gel.Some examples of cellulosic gum may include ‘Klucel’ GF, a hydroxymethylpropylcellulose from Hercules.

In addition to the addition of heat, light and/or chemicals, the amountof whitening obtained during a bleaching process is generally dependentupon (1) the length of time the teeth is in contact with the whiteningagent; (2) the number of days the treatment is carried out; (3) thesusceptibility of the teeth to the bleaching agent and (4) concentrationof active peroxide, as noted above. For maximum whitening, a longtreatment time with a highly concentrated bleaching composition isgenerally recommended, as noted before.

Bleaching activity of a peroxide compound is generally dictated by theavailability of active peroxides, and not generally by the actualconcentration of peroxide present in the composition. When peroxide ispresent in solution, active peroxides are readily available. However, asolution, by its nature, is not easily contained, and/or not amenablefor sustain action when applied to a patient's teeth, again because itis difficult to confine it to any desired location for any length oftime. Thus, a less concentrated peroxide solution requiring longercontact time to be effective is not practical in a solution environment.A more concentrated solution of peroxide, though more efficient inbleaching, is likewise not suitable in a solution environment because itwill not solve the confinement and prolonged contact problem. Inaddition, any concentrated peroxide solution that may come into contactwith soft tissue inside a patient's mouth may potentially cause tissuedamage. Therefore, to maintain effective bleaching with good containmentso as to minimize potential tissue damage, various gelling agents,thickeners, adhesion promoters and/or similar additives may be used, asdiscussed above in the unfoamed system. These result in the formation ofpaste, gels, and similar forms, which are effective whitening systems.It is surmised that some of the additives used, though effective incontainment and bleaching, may somewhat decrease the bleaching activityby inhibiting the availability of active peroxides, especially if thecomposition contain thickeners or adhesion promoters derived frompolymers of acrylic acid (carbomer), pyrrolidone analog thickeners, orothers. Such additives may lead to diminished whitening capacity ofperoxides through ionic and covalent interactions within the gel, andact against the desired effect of tooth whitening.

Foaming may be another way to improve substantivity without some of theabove mentioned additives. Foamed compositions may also provideprolonged contact without high amounts of additives that may tend tosomewhat inhibit the activity of active peroxides, thus furtherimproving the whitening activity. Foams may be formulated with the sameor higher amounts of active ingredients and smaller amounts of inactiveingredients. In a given volume, smaller amounts of inactive ingredientssuch as gelling agents, thickeners, adhesion promoters or similar may bepresent in the foamed state compared to unfoamed state. Without wishingto be bound to a theory, it is surmised that air performs the functionof an inactive ingredient such as a gelling agent, a thickener, anadhesion promoter or mixtures thereof, to give the needed substantivity;but air molecules in general do not inhibit the availability of activeperoxides to the same extent as other inactive ingredients needed forsubstantivity in an unfoamed gel. Thus, a foamed composition has thesubstantivity of a composition having higher amounts of ingredients suchas gelling agents, thickeners, adhesion promoters or similar inactiveingredients, but with more availability of active peroxides forbleaching action even if the same concentration of peroxide is present.In other words, foaming may in effect substitute air bubbles for gellingagents to create substantivity.

Thus, a foamed or foamable composition of the present invention mayincrease the rate of whitening activity, if desired, without theproblems encountered by solutions. Not only is a foamed compositionmanageable without confinement problems during use, it may also becapable of delivering a high concentration of active peroxide by notinhibiting the availability of active peroxides, and at the same time,may also seek to fill crevices, sometimes seeping into gaps where gapsare not apparent, thus offering effective whitening action not only tothe front surface of a tooth, but surfaces in-between teeth as well.Therefore, foaming may potentially provide all the benefits that are notcurrently available to other whitening systems.

Foams in general also have lower surface tension than their unfoamedcounterparts and may therefore be spread as thin as one molecule thicksheets, while at the same time increasing its surface area, thuscovering more area with the same volume of whitening composition thantheir unfoamed counterparts. The ability to lower surface tension mayalso make the stains easier to remove.

The foamed bubbles, through the forces of capillary action and loweredsurface tension, are also themselves good wetting agents, so that ableaching solution may penetrate through smaller openings, as notedabove. The rapid penetration into the tightest spots may also be aidedby the distribution of the sizes and shapes of bubbles. Thus, foams mayeven cause deeper penetration of active peroxide molecules.

It is further surmised that active peroxides may also be captured insidethe bubbles of foams. As the bubbles collapse, the active peroxide agentis released to perform whitening actions.

The foamed or foamable composition of the present invention not only hasadvantages over unfoamed gels, as discussed above, such as flowingbetween enamel rods, and insuring that more active ingredients get tothe areas not previously reachable, but may also provide bettersustained action in a home use setting.

For home use, a tray is generally used for sustain contact between thewhitening composition and the surface of tooth or teeth to effectwhitening. Compositions in the art generally use additives having highadhesion strength to help retain the composition and even the tray inplace. Foams may provide such sustain contact without resorting to theuse of the kind of adhesion promoting additives used in the art. Foamsmay also more evenly spread any stress exerted on the teeth or tray. Inaddition, foamed compositions have lower density and thus are moreamenable for sustain contact without gravity drag. Thus, foams not onlyfacilitate the whitening action but may also facilitate the ease ofapplication, penetration into difficult to reach areas, retention andremoval. It is further surmised that the active whitening ingredientsmay be captured inside the bubbles and such bubbles may serve ascontrolled whitening devices by metering the amount of active peroxidesacting on the teeth over time as the bubbles collapse.

In some embodiments, the foamed composition may be made duringmanufacturing of the gels and may be packaged accordingly. Foamformation may be effected by any agitation or whipping action, use offoaming agents and combinations thereof. Such foams may be made to belong lasting with a desired shelf life, for example, at least about amonth.

In other embodiments, foaming agents may be present to render thecomposition foamable so that foams are generated just prior to use. Somefoaming agents may also aid in increasing the adhesion of the gel to asolid surface by allowing it to spread over a greater surface area.

In still other embodiments, foams may be formed just prior to use byagitation with or without any foaming agent.

Thus, some compositions include at least one foaming agent. Differentcategories of foaming agents are suitable, and they may produce foams indifferent ways. Suitable foaming agents may include certain surfactantssuch as anionic, nonionic, amphoteric, zwitterionic, cationic, ormixtures thereof.

Some of these aids in foam formation and some do not. Some surfactantsare useful purely for their foaming properties alone, some act only asemulsifiers or wetting agents without foaming, and some even act toreduce foaming. The functions of the surfactants are not necessarilydetermined by the category they belong to.

Anionic surfactants include, but not limited to water-soluble salts ofalkyl sulfates having from about 8 to about 20 carbon atoms in the alkylradical (such as sodium alkyl sulfate), water-soluble salts ofsulfonated monoglycerides of fatty acids having from about 8 to about 20carbon atoms and mixtures thereof. Examples of anionic surfactantsinclude Sodium lauryl sulfate, sodium coconut monoglyceride sulfonates,phospholipids, sarcosinates, such as sodium lauryl sarcosinate,taurates, sodium lauryl sulfoacetate, sodium lauroyl isethionate, sodiumlaureth carboxylate, and sodium dodecyl benzenesulfonate. Many of theseanionic surfactants are disclosed in U.S. Pat. No. 3,959,458, thecontent of which is incorporated herein in its entirety by reference.

Nonionic surfactants may include, but not limited, to compoundsincluding a hydrophilic and hydrophobic components (which maybe producedby the condensation of alkylene oxide groups (hydrophilic in nature)with an organic hydrophobic compound which may be aliphatic oralkyl-aromatic in nature). Examples of suitable nonionic surfactantsinclude low viscosity poloxamers (sold under the trade name Pluronic),low viscosity hydroxyethyl cellulose, polysorbates, polyoxyethylenesorbitan esters (sold under the trade name Tweens), fatty alcoholethoxylates, polyethylene oxide condensates of alkyl phenols, productsderived from the condensation of ethylene oxide with the reactionproduct of propylene oxide and ethylene diamine, ethylene oxidecondensates of aliphatic alcohols, long chain tertiary amine oxides,long chain tertiary phosphine oxides, long chain dialkyl sulfoxides, andmixtures thereof.

Amphoteric surfactants may include, but is not limited to derivatives ofaliphatic secondary and tertiary amines in which the aliphatic componentmay be a straight chain or branched and one of the aliphaticsubstituents contains from about 8 to about 18 carbon atoms and onecontains an anionic water-solubilizing group, such as carboxylate,sulfonate, sulfate, phosphate, phosphonate, betaines, specificallycocamidopropyl betaine, and mixtures thereof.

Many of these nonionic and amphoteric surfactants are disclosed in U.S.Pat. No. 4,051,234, the content of which is incorporated herein byreference in its entirety.

In the present invention, the exemplified surfactants, when used infoamable compositions, are those that not only have some foamingcapabilities, but also those with some ability to act as wetting agents.

Actually, any asymmetrical molecule dissolved in water will make atleast a weak surfactant. Such weak surfactants may normally not be aneffective foaming agent, but its effectiveness may be improved if afoaming dispenser is used. Asymmetrical molecules as used herein includethose that include a hydrophilic and a hydrophobic segment, such as someof the nonionic surfactants mentioned above. One end of the molecule isthus polar in nature and dissolves in water, while the other end isnonpolar in nature and avoids water. When in water, the surfactantmolecules oriented themselves with their polar ends towards the watermolecules, leaving the nonpolar ends free to attract nonpolar molecules.It is surmised that in a foamed or foamable composition of the presentinvention, the non-polar ends help to lift tooth surface stains,allowing them to be washed away with the water.

The amount of foaming agents may range, for example, from about 0.1% toabout 5% by weight of the foamable composition, more for example, fromabout 0.5% to about 3% by weight, even more for example, less than about1% by weight.

Still other foaming agents may include reaction products of any basewith an acid. These may include, for example, an alkali metal carbonateor bicarbonate, such as sodium bicarbonate, potassium bicarbonate,sodium carbonate or potassium carbonate, or an alkaline metal carbonateor bicarbonate such as magnesium or calcium bicarbonate or carbonate.The amount used may range, for example, from about 1% to about 10% byweight, more for example, from about 3% to about 7%, still more forexample, from about 3.5 to about 5.5% by weight of the composition. Theamount used may also depend on the volume of foam required. Thus, byvarying the amount of foaming agents, the amount of foam produced may bevaried accordingly.

Generally, the ratio of acid and base ranges, for example, from about1:0.5 to 1:25, more for example, from about 1:1 to 1:4, by weight.Suitable acids include strong acids such as water soluble carboxylicacids, phosphoric acids, nitric acids, and/or sulfuric acids.

Additionally, a foaming agent may also be a gaseous material. Thegaseous material may be any inert gas or a gas generated by mixing abasic peroxide solution with an acid solution.

Since the whitening activity results when active peroxide comes intocontact with the tooth, the foams generated just prior to use may forexample, not need to be too long lasting, if the active ingredients aresurmized to be captured within the bubbles, but have a substantive bodyso that the amount of liquid formed, i.e., the collapsing of the foambubbles to release active peroxide, may be controlled and balanced.Therefore, the exemplary compositions are not only foamable, but arealso capable of producing longer lasting, collapsible foams.

The foams generated by a foamable composition generally have half livesof, for example, from about 1 to 10 hours, more for example, from about2 to 5 hours. A foam having a half life of 2 hours means that 50% of thebubbles would collapse to release the encapsulated whitening agent, orthat the volume of the foam is reduced by 50% in about 2 hours afterformation, and 75% of all the bubbles are gone, or the volume of thefoam is reduced by 75% in about 4 hours.

The collapse time or half lives of the foam depends on a number offactors. For example, the greater the amount of bubbles formed, thelonger the collapse time. Also, the lower the viscosity of thethickeners, and/or other inactive ingredients, the shorter the collapsetime. The collapse time may also depend on the nature of the otheradditives to the composition, which have surface active properties e.g.,surfactants or preservatives as well as the environment. For example, adrier environment may contribute to faster collapse of bubbles.

For foamed compositions, the collapsible bubbles typically have veryextended half lives when confined in the package, for example, at leastabout a month, more for example, at least about three months. Duringuse, the collapse of the foamed bubbles is aided by the environment,such as the loss of water or solvent to the environment, and the salivain the patient's mouth. A packaging may be designed so that a foamedcomposition may have a desired shelf life after the package or containerhas been opened and the remaining has been exposed to air. A single-usepackaging may also be designed.

For example, a lower viscosity gelling agent or thickener may be used.They are not as likely to inhibit the availability of active peroxidesto the same extent as a higher viscosity gelling agent. The viscosity isfor example, generally less than about 10,000 cps, more for example,less than about 8,000 cps, and even more for example, less than about5,000 cps.

Suitable foaming agents include foamable surfactants including at leastsome sodium lauryl Sulfate as the primary foaming agent.

As discussed above, substantivity, i.e. the ability of a product tolinger, is a desirable property in any whitening composition. On theother hand when the desired property of a product is the ability to berinsed off easily, a foaming surfactant would not be used. However,there is a general desire that a whitening composition may both havesubstantivity and the ease to be rinsed off. When this is desired, foamsgenerated in a “foaming pump”, a dispensing tip adapted for foaming, ora dispensing tip including a mixer adapted for foaming may be used. Suchfoaming devices again may produce foams with desirable properties, whileusing a minimum of amount of surfactants, for example, less than about0.5%. At the same time, some combinations of additives may be chosen toproduce the desired effect as well, such as by the addition of otherfoaming agents.

For remineralizing effects, amorphous calcium compounds may be used.Amorphous calcium compounds such as amorphous calcium phosphate (ACP),amorphous calcium phosphate fluoride (ACPF), amorphous calcium carbonatephosphate (ACCP), amorphous calcium carbonate phosphate (ACCP), andamorphous calcium carbonate phosphate fluoride (ACCPF) may be used inremineralizing teeth. These amorphous compounds are disclosed in U.S.Pat. Nos. 5,037,639, 5,268,167, 5,437,857, 5,562,895, 6,000,341, and6,056,930, the disclosure of each is hereby incorporated by reference inits entirety.

In addition to amorphous calcium compounds, amorphous strontiumcompounds such as amorphous strontium phosphate (ASP), amorphousstrontium phosphate fluoride (ASPF), amorphous strontium calciumphosphate (ASCP), amorphous strontium calcium carbonate phosphate(ASCCP), amorphous strontium carbonate phosphate fluoride (ASCPF) andamorphous strontium calcium carbonate phosphate fluoride (ASCCPF) may beused in re-mineralization, as noted above. These compounds are disclosedin U.S. Pat. No. 5,534,244, the content of which is hereby incorporatedby reference in its entirety.

Some of the compounds mentioned above may also be used in fluoridatingteeth. All of the above amorphous compounds or solutions which form theamorphous compounds, when applied either onto or into dental tissue, mayaid to prevent and/or repair dental weaknesses such as dental caries,exposed roots and dentin sensitivity.

For example, the first component of the whitening system may include asource of phosphate and the second component may include a source ofcalcium or strontium.

For example, the source of phosphate in the first component may includemonosodium phosphate (NaH₂PO₄), disodium phosphate, tetrapotassiumpyrophosphate or mixtures thereof. As discussed above, the secondcomponent may include a source of calcium or strontium, and when the twogel components are mixed, may combine with phosphate to form the variousamorphous calcium and/or strontium phosphates.

The source of phosphate may be, for example, present in an amount offrom about 0.2% to about 5% by weight, more for example, between about0.2% to about 4% by weight.

The source of calcium, strontium or combinations thereof in the secondcomponent may include, for example, a calcium salt, a strontium salt, ormixtures thereof, more for example, a calcium salt such as calciumnitrate, in an amount of, for example, from about 0.25% by weight toabout 1.5% by weight, more for example, about 0.3% to about 1% byweight.

In practice, as much phosphate as possible or practicable may beincluded. However, amounts of monosodium phosphate in excess of about 4%by weight may tend to affect gel stability.

Surprisingly, the phosphate component present in the first componentaccording to the ranges mentioned above may also act to stabilize thegel. At higher levels, the stabilizing effect gradually disappears.

Additionally, the phosphate salt may further act to adjust the pH of thefirst component. The pH of the system may be, for example, from about 5to about 8, more for example, from about 5.5 to about 6.5.

Surprisingly, the amorphous calcium and/or strontium salts present inthe composition may also act as sensitivity relief agents. In fact, thepresent inventors have found that the de-sensitizing effect provided byamorphous calcium phosphate is at least as effective as, if not moreeffective than, the typical de-sensitizing agents normally used,including some of those discussed below. Therefore, the presence ofamorphous calcium and/or strontium salts may potentially replacetraditional de-sensitizing agents.

Additional de-sensitizing agents may also be used. Suitabledesensitizing agents, if added, may include, for example, alkalinitrates such as potassium nitrate, sodium nitrate and lithium nitrate;and other potassium salts such as potassium chloride and potassiumbicarbonate.

The percent of desensitizing agent may be present, for example, up toabout 5 percent by weight, more for example, up to about 4 percent byweight, and even more for example, up to about 3 percent by weight.

The de-sensitizing agent may be present in both components of the systemand the ranges present above may represent the total in both components.For example, the de-sensitizing agent may be present in approximatelyequal amounts in each component.

Surprisingly, the de-sensitizing agent also acts to stabilize the gel.

In addition, optional additives including humetants, flavorings,coloring agents, anti-plaque agents, anti-staining compounds, pHadjusting agents, excipients such as emollients, preservatives, othertypes of stabilizers such as antioxidants, chelating agents, tonicitymodifiers (such as sodium chloride, manitol, sorbitol or glucose),spreading agents, and water soluble lubricants, such as propyleneglycol, glycerol or polyethylene glycol. The concentration of each mayeasily be determined by a person skilled in the art. Some of these maybe contemplated for a foamed or foamable system.

The humectants contemplated for use in the inventive compositionsinclude water, polyols, such as glycerol, sorbitol, polyethyleneglycols, propylene glycols, hydrogenated partially hydrolyzedpolysaccharides and the like. A single humectant or a combination isalso contemplated. They are generally present in amounts of, forexample, up to about 85%, more for example, from about 15% to about 75%of the formulation. For foamable compositions, the amount of humectantpresent tends more towards the high end of the range.

As mentioned above, lower peroxide content compositions may becontemplated. These low peroxide compositions may be used at home overlonger period of time and may be used as a vehicle for the delivery ofmany other agents that may be beneficial to oral and general health.These compositions may also be used after an in-office whiteningtreatment to maintain the effect. In addition, a remineralizingcomposition adapted for prolong use may be beneficial to damaged toothor teeth, severe caries, or even bone loss.

In one embodiment, the system may include a low peroxide contentwhitening composition having remineralizing effect. In anotherembodiment, the system includes a low peroxide content whiteningcomposition having remineralizing effect with sensitivity relief. In yetanother embodiment, the system may include a low peroxide contentwhitening composition having remineralizing effect and fluoridetreatment. In a further embodiment, the system may include a lowperoxide content whitening composition having remineralizing effect,fluoride treatment and anti-bacterial effect.

In more embodiments, any of the combination effects desired may beachieved. In even more embodiments, other agents, including anti-plaqueagents, anti-staining agents, vitamin supplements or others that may bebeneficial to teeth, breath or even general health care may be included.

The peroxide content may be in the low end of the range mentioned above,for example, from about 0.5 to about 5%, more for example, from about0.5 to about 3%. The composition may be foamed or unfoamed.

Though the amorphous calcium and/or strontium salts present in thecomposition may also act as sensitivity relief agents, additionalde-sensitizing agents, such as the potassium salts and similar mentionedabove may also be added for additional effect.

Useful fluoridating agents may include metal fluoride salts such assodium fluoride, sodium monofluorophosphate, potassium fluoride, lithiumfluoride, ammonium fluoride, stannous fluoride; zinc ammonium fluoride,tin ammonium fluoride, calcium fluoride and cobalt ammonium fluoride,and water soluble amine hydrofluorides. Generally, sodium fluoride andstannous fluoride.

Some amorphous calcium and strontium salts may also be usefulfluoridation agents and include amorphous calcium phosphate fluoride(ACPF), amorphous calcium carbonate phosphate fluoride (ACCPF) (asdisclosed in U.S. Pat. Nos. 5,037,639, 5,268,167, 5,437,857, 5,562,895,6,000,341, and 6,056,930, the disclosure of each is hereby incorporatedby reference in its entirety), amorphous strontium phosphate fluoride(ASPF), amorphous strontium carbonate phosphate fluoride (ASCPF) andamorphous strontium calcium carbonate phosphate fluoride (ASCCPF) (asdisclosed in U.S. Pat. No. 5,534,244, the content of which is herebyincorporated by reference in its entirety). These compounds may haveboth remineralizing and fluoridating effects.

Useful antibacterial agents include, for example, phenolics andsalicylamides, and sources of certain metal ions such as zinc, copper,silver and stannous ions, for example in salt form such as zinc, copperand stannous chloride, and silver nitrate. These are again present insmall quantities when used.

In foamed or foamable form, the advantages of foams mentioned above arealso realized in these low peroxide content whitening compositions.

In packaging the tooth whitening composition of the present invention,any convenient way for effecting the separation of the two componentsbefore use may be utilized. For example, a single container may becompartmentalized so that the two components are housed in separatecompartments and are dispensed simultaneously and admixed prior toapplication on the teeth. Alternatively, the two components may behoused in separate containers from which the respective components aredispensed for admixture just prior to use. An exemplary packaging isdisclosed in U.S. Pat. Nos. 5,819,988, 6,065,645, 6,394,314, 6,564,972and 6,698,622, incorporated herein by reference.

In one exemplary embodiment of the present invention, the two componentsare provided in separate chambers of a dual barrel syringe. In anotherexemplary embodiment of the invention, the two components of the systemare provided in a container having separate compartments for thecomponents.

In any of the packaging methods described, the syringe or thedual-compartment container may be provided with a dispensing tip, or adispensing tip including a mixer. The mixers may be dynamic or static.Examples of static mixers may include those also disclosed in U.S. Pat.Nos. 5,819,988, 6,065,645, 6,394,314, 6,564,972 and 6,698,622,incorporated herein by reference. Examples of some dynamic mixers mayinclude those disclosed in may include those disclosed in U.S. Pat. Nos.6,443,61, and 6,457,609; and U.S. Patent Publication No. 2002/0190082;the contents of these are hereby incorporated by reference.

Such dispensing tips or mixers may also be adapted for foaming or thesyringe or container is provided with a dispensing pump.

Immediately before use, the two components are mixed together in a 1:2to a 5:1 ratio (first component to second component) by actuating thesyringe or the container. For example, the gels or foams may be mixed inthe 1:1 ratio. The admixed whitening gel or foam is applied to thesurface of the teeth directly from the syringe or by means of a dentalbleaching tray. Other combinations of the components are contemplated bythe present invention, depending on the % variation of ingredientspresent in each component.

Surprisingly, apart from the components for the amorphous compound, suchas the source of phosphate and the source of calcium, strontium ormixture, the two components may include approximately the same activeingredients. When the two components of the exemplified embodiment aremixed, the two sources may combine to form calcium phosphate. Whenapplied to the teeth, the calcium phosphate may precipitate onto thesurface of the teeth where it may be incorporated into hydroxyapatite,assisting in remineralization of the tooth enamel, as discussed in U.S.Pat. Nos. 5,037,639, 5,268,167, 5,460,803, 5,534,244, 5,562,895,6,000,341, and 6,056,930, noted above. The activity of the amorphouscalcium and/or strontium compounds is not compromised, even if thesource of peroxide and other active ingredients are present in bothcomponents. This may result in improved manufacturing efficiency.

In addition, to visibly distinguish the two components, the firstcomponent may be made to be substantially milky, cloudy, opaque orcolored, while the second component may be made to be substantiallyclear, or vice versa. In addition, both may be made to be substantiallymilky, cloudy, opaque or colored, and the distinction is by degree or bycolor.

Most opacifying agents tend to decrease the stability of peroxide; forexample, TiO₂ or ZnO₂ may cause the decomposition of peroxide, making itless effective for its intended purposes. Surprisingly, CaCO₃ is foundto be an effective pigment as well as a mixture of mica and TiO₂stabilized with an EDTA salt. Both were found not to affect the peroxidestability, and a white first component resulted. Other opacifying agentshaving the same effect is also contemplated.

The present invention is further described by the following examples.The ingredients in B were mixed in a Kitchenaide mixer until thehydroxymethyl propylcelluose, available from Hercules Incorporated,Aqualon Division, Hercules Plaza (Wilmington, Del.) and the emulsifyingwax were dispersed in the propylene glycol. Then, the ingredients in Awere added and mixed together prior to the addition of the ingredientsin C. Afterwards, the flavoring and silica in C were added to thethickened dispersion with moderate mixing until dispersed. Finally, ifused, Timica Extralarge Sparkle 110S (titanium dioxide/mica, availablefrom Engelhard Corporation, Iselin, N.J.) was added and mixed undervacuum to remove all air/foam. On the other hand, when foamedcompositions are made, such foam removal action is not needed, while atthe same time, agitation for additional foam production is used. Also,for foamable compositions, foaming agents are added. In either foamed orfoamable compositions, a decreased amount of gelling agents, thickenersand/or other inactive ingredients may or may not be present. FirstComponent, Composition 1 % Grams Phase 50% Hydrogen peroxide 50% water3.62 10.86 A TKPP tetrapotassium pyrophosphate 0.2 0.6 A Glycerin 20 60A2 carbamide peroxide urea hygrogen peroxide 17 51 A2 Antifoaming Agentsilicone emulsion/Dimethyl polysiloxan QS QS A2 emulsion/“Dow” Klucel GFhydrxypropyl methyl cellulose “Hercules” 1.981 105 B propylene glycol“Westco” 45.733.019 Propylene Glycol “Westco” 12.68 38.04 B Polawax NFemulsifying wax NF “Croda” 6.5 19.5 B Combine A & B in C “Kitchenaide”Cabosil EH-5 fumed silica/“Cabot” 4.5 13.5 C Natural Mint natural mintflavoring 0.5 1.5 C

First Component, Composition 2 % Grams Phase Water 4.62 13.86 A TKPP 0.20.6 A Glycerin 20 60 A2 carbamide peroxide 16 48 A2 Antifoaming agent QSQS A2 Klucel GF 35 105 B Propylene Glycol 12.68 38.04 B Polawax NF 6.519.5 B Combine A & B in “Kitchenaide” C Cabosil EH-5 4.5 13.5 C Mint 0.51.5 C 100

First Component, Composition 3 % Grams Phase Water 6.82 20.46 A 50% H₂0₂5.8 17.4 A TKPP 0.2 0.6 A Glycerin 20 60 A2 carbamide peroxide 8 24 A2Antifoaming agent QS QS A2 Klucel GF 35 105 B Propylene Glycol 12.6838.04 B Polawax NF 6.5 19.5 B Combine A & B in “Kitchenaide” C CabosilEH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100

First Component, Composition 4 % Grams Phase Water 9 27 A 50% H₂0₂ 5.817.4 A TKPP 0.2 0.6 A Glycerin 19 57 A2 carbamide peroxide 8 24 A2Antifoaming agent QS QS A2 Klucel GF 34.5 103.5 B Propylene Glycol 12 36B Polawax NF 6.5 19.5 B Combine A & B in “Kitchenaide” C Cabosil EH-54.5 13.5 C Natural Mint 0.5 1.5 C 100

First Component, Composition 5 % Grams Phase Water 12.5 37.5 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A glycerin 16.8 50.4 A2 carbamide peroxide 6 18A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B Propylene Glycol 11.835.4 B Polawax NF 6.5 19.5 B Combine A & B in “Kitchenaide” C CabosilEH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100

First Component, Composition 6 % Grams Phase Water 12.5 37.5 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 16.3 48.9 A2 carbamideperoxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B PropyleneGlycol 10.55 31.65 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” CTimica blend 0.25 0.75 Cabosil EH-5 4.5 13.5 C Natural Mint 0.5 1.5 C100 300

First Component, Composition 7 % Grams Phase Water 12.5 37.5 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 16.3 48.9 A2 carbamideperoxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B PropyleneGlycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in “Kitchenaide” CTimica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.5 13.5 C Natural Mint0.5 1.5 C 100 300

First Component, Composition 8 % Grams Phase Water 12.5 38.1 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A Glycerin 16.8 50.4 A2 carbamide peroxide 6 18A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B Propylene Glycol 11.835.4 B Polawax NF 6.5 19.5 B Combine A & B in “Kitchenaide” C CabosilEH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100

First Component, Composition 9 % Grams Phase Water 12.5 37.5 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A Na₂HPO₄ (di-sodium) 0.5 1.5 A NaH₂PO₄(monosodium) QS QS A KNO₃ 2 6 A Glycerin 16 48 A2 carbamide peroxide 618 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B Propylene Glycol9.95 29.85 B Polawax NF 6 18 B Combine A & B in “Kitchenaide” C Timicablend/Titanium Dioxide and Mica/ 0.5 1.5 “Englehard” TiO₂ 0.25 0.75Cabosil EH-5 4.4 13.2 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 10 % Grams Phase Water 12.7 38.1 A 50% H₂0₂0 0 A TKPP 0.2 0.6 A Na₂HPO₄ (di-sodium) 0.5 1.5 A NaP₂PO₄ (monosodium)QS QS A KNO₃ 2 6 A Glycerin 14 42 A2 carbamide peroxide 12 36 A2Antifoaming agent QS QS A2 Klucel GF 37 111 B Propylene Glycol 9.9529.85 B Polawax NF 6 18 B Combine A & B in “Kitchenaide” C Timica blend0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.4 13.2 C Natural Mint 0.5 1.5 C100 300

First Component, Composition 11 % Grams Phase Water 12.5 37.5 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A NaH₂PO₄ (monosodium) 0.5 1.5 A Na₂HPO₄(di-sodium) QS QS A KNO₃ 2 6 A Glycerin 16 48 A2 carbamide peroxide 6 18A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B Propylene Glycol 9.9529.85 B Polawax NF 6 18 B Combine A & B in “Kitchenaide” C Timica blend0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.4 13.2 C Natural Mint 0.5 1.5 C100 300

First Component, Composition 12 % Grams Phase Water 8.3 24.9 A 50% H₂0₂8.4 25.2 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 16.3 48.9 A2 carbamideperoxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B PropyleneGlycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in “Kitchenaide” CTimica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.5 13.5 C Natural Mint0.5 1.5 C 100 300

First Component, Composition 13 % Grams Phase Water 12.5 37.5 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 16.3 48.9 A2 carbamideperoxide 11.5 34.5 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 105.5 316.5

First Component, Composition 14 % Grams Phase Water 12.3 36.9 A 50% H₂0₂4.2 12.6 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 11 33 A2 carbamide peroxide11.5 34.5 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B PropyleneGlycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in “Kitchenaide” CTimica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.5 13.5 C Natural Mint0.5 1.5 C 100 300

First Component, Composition 15 % Grams Phase Water 9.5 28.5 A 50% H₂0₂10.1 30.3 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 11.3 33.9 A2 carbamideperoxide 8.1 24.3 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 16 % Grams Phase Water 12.5 37.5 A 50% H₂0₂5.3 15.9 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 9.65 28.95 A2 carbamideperoxide 14.6 43.8 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 7 21 B Polawax NF 6 18 B Combine A & B in “Kitchenaide”C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.5 13.5 C NaturalMint 0.5 1.5 C 100 300

First Component, Composition 17 % Grams Phase Water 5 15 A 50% H₂0₂ 11.835.4 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 6 18 A2 carbamide peroxide 16.248.6 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 B Propylene Glycol10.05 30.15 B Polawax NF 6 18 B Combine A & B in Kitchenaide C Timicablend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.5 13.5 C Natural Mint 0.51.5 C 100 300

First Component, Composition 18 % Grams Phase Water 9.2 27.6 A 50% H₂0₂7.7 23.1 A TKPP 0.2 0.6 A KNO₃ 2 6 A Glycerin 16.6 49.8 A2 carbamideperoxide 5.5 16.5 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 C TiO₂ 0.25 0.75 C Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 19 % Grams Phase Water 9.2 27.6 A 50% H₂0₂7.7 23.1 A TKPP 0.2 0.6 A KNO₃ 2 6 A Glycerin 16.6 49.8 A2 carbamideperoxide 5.5 16.5 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Crodaphos 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 C TiO₂ 0.25 0.75 C Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 20 % Grams Phase Water 9.5 28.5 A 50% H₂0₂10.1 30.3 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 11.3 33.9 A2 carbamideperoxide 8.1 24.3 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Crodaphos 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 21 % Grams Phase Water 8.3 24.9 A 50% H₂0₂8.4 25.2 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 17.8 53.4 A2 carbamideperoxide 4.5 13.5 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 22 % Grams Phase Water 8.3 24.9 A 50% H₂0₂7.3 21.9 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 17.3 51.9 A2 carbamideperoxide 6.1 18.3 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 23 % Grams Phase Water 8.3 24.9 A 50% H₂0₂7.3 21.9 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 17.3 51.9 A2 carbamideperoxide 6.1 18.3 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.55 31.65 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0 0 C 100 300

First Component, Composition 24 % Grams Phase Water 8.3 41.5 A 50% H₂0₂8.4 42 A TKPP 0.2 1 A KNO₃ 2 10 Glycerin 18.3 91.5 A2 carbamide peroxide4.5 22.5 A2 Antifoaming agent QS QS A2 Klucel GF 37 185 B PropyleneGlycol 10.05 50.25 B Polawax NF 6 30 B Combine A & B in “Kitchenaide” 0C Timica blend 0.5 2.5 TiO₂ 0.25 1.25 Cabosil EH-5 4.5 22.5 C NaturalMint 0 0 C 100 500

First Component, Composition 25 % Grams Phase Water 12.5 37.5 A 50% H₂0₂3.3 9.9 A TKPP 0.2 0.6 A KNO₃ 2 6 Glycerin 17.7 53.1 A2 carbamideperoxide 5.5 16.5 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 26 % Grams Phase Water 12.5 37.5 A 50% H₂0₂3.3 9.9 A TKPP 0.2 0.6 A KNO₃ 0 0 Glycerin 18.7 56.1 A2 carbamideperoxide 5.5 16.5 A2 Antifoaming agent QS QS A2 Klucel GF 38 114 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 27 % Grams Phase Water 8.3 24.9 A 50% H₂0₂8.4 25.2 A TKPP 0.2 0.6 A KNO₃ 0 0 Glycerin 18.8 56.4 A2 carbamideperoxide 4.5 13.5 A2 Antifoaming agent QS QS A2 Klucel GF 38 114 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 28 % Grams Phase Water 9.5 28.5 A 50% H₂0₂10.1 30.3 A TKPP 0.2 0.6 A KNO₃ 0 0 Glycerin 12.3 36.9 A2 carbamideperoxide 8.1 24.3 A2 Antifoaming agent QS QS A2 Klucel GF 38 114 BPropylene Glycol 10.05 30.15 B Polawax NF 6 18 B Combine A & B in“Kitchenaide” C Timica blend 0.5 1.5 TiO₂ 0.25 0.75 Cabosil EH-5 4.513.5 C Natural Mint 0.5 1.5 C 100 300

First Component, Composition 29 % Grams Phase Water 8.3 12.45 A 50% H₂0₂8.4 12.6 A TKPP 0.2 0.3 A EDTA 0.5 0.75 KNO₃ 2 3 Glycerin 17.55 26.325A2 carbamide peroxide 4.5 6.75 A2 Antifoaming agent QS QS A2 Klucel GF37 55.5 B Propylene Glycol 10.05 15.075 B Polawax NF 6 9 B Combine A & Bin “Kitchenaide” C Timica blend 0.5 0.75 TiO₂ 0 0 Cabosil EH-5 4.5 6.75C Natural Mint 0.5 0.75 C 100 150

To summarize, the range of ingredients in the first component in theabove examples are as follows:

a 50% hydrogen peroxide solution is, for example, from about 2% to about15%, more for example, from about 4% to about 12%; carbamide peroxideis, for example, from about 3% to about 20%, more for example, fromabout 4% to about 17.0%; aerosol, such as Cabosil EH-5, is, for example,from about 2% to about 5%, more for example, about 4.5%; glycerin is,for example, from about 5% to about 25%, more for example, from about 6%to about 20.0%; gelling agent such as Klucel GF is, fro example, fromabout 1% to about 40%, more for example, from about 2% to about 38%,Polawax NF is, for example, from about 5% to about 10%, more forexample, from about 5% to about 7%; propylene glycol is, for example,from about 5% to about 15%, more for example, from about 7% to about13%, and timica blend/titanium dioxide and mica/“Englehard” is, forexample, from about 0.2% to about 1%, more for example, from about 0.25%to about 0.75%. Other ranges may be used without detracting from thepresent invention. Second Component, Composition 1 % Grams Phase Water9.35 28.05 A 50% H₂O₂ 8 24 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 0 0A Glycerin 21 63 A2 carbamide peroxide 5.1 15.3 A2 Antifoaming Agent QSQS A2 Klucel GF 40 120 B Propylene Glycol 8.3 24.9 B Polawax NF 1.253.75 B Combine A & B in “Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint0.5 1.5 C 100 300

Second Component, Composition 2 % Grams Phase Water 4.72 14.46 A 10% KOHQS QS A Ca(NO₃)₂ 0.5 1.5 A Glycerin 20 60 A2 carbamide peroxide 16 48 A2Antifoaming Agent QS QS A2 Klucel GF 35 105 B Propylene Glycol 12.1836.54 B Polawax NF 6.5 19.5 B Combine A & B in “Kitchenaide” C CabosilEH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 3 % Grams Phase Water 7.02 21.06 A 50%H₂O₂ 5.8 17.4 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A Glycerin 20 60 A2carbamide peroxide 8 24 A2 Antifoaming Agent QS QS A2 Klucel GF 35 105 BPropylene Glycol 12.18 36.54 B Polawax NF 6.5 19.5 B Combine A & B in“Kitchenaide” C Cabosil EH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 4 % Grams Phase Water 9 27 A 50% H₂O₂ 5.817.4 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A Glycerin 18.7 56.1 A2carbamide peroxide 8 24 A2 Antifoaming agent QS QS A2 Klucel GF 34.5103.5 B Propylene Glycol 12 36 B Polawax NF 6.5 19.5 B Combine A & B in“Kitchenaide” C Cabosil EH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 5 % Grams Phase Water 12.5 37.5 A 50% H₂O₂4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A Glycerin 16.5 49.5 A2carbamide peroxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF 37 111 BPropylene Glycol 11.8 35.4 B Polawax NF 6.5 19.5 B Combine A & B in“Kitchenaide” C Cabosil EH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 6 % Grams Phase Water 12.5 37.5 A 50% H₂O₂4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A Glycerin 17 51 A2carbamide peroxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF 41 123 BPropylene Glycol 12.3 36.9 B Combine A & B in “Kitchenaide” C CabosilEH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 7 % Grams Phase Water 13.5 40.5 A 50% H₂O₂4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin 14.543.5 A2 carbamide peroxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF41 123 B Propylene Glycol 11.8 35.4 B Combine A & B in “Kitchenaide” CCabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 8 % Grams Phase Water 12.5 37.5 A 50% H₂O₂4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin 15 45A2 carbamide peroxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF 39117 B Propylene Glycol 12.3 36.9 B Polawax NF 2 6 B Combine A & B in“Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 9 % Grams Phase Water 13.25 39.75 A 50%H₂O₂ 4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin19 57 A2 carbamide peroxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A &B in “Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 10 % Grams Phase Water 13.75 41.25 A 50%H₂O₂ 4.2 12.6 A 10% KOH QS QS A KNO₃ 2 6 A Glycerin 19 57 A2 carbamideperoxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF 39 117 B PropyleneGlycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A & B in “Kitchenaide”C Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 11 % Grams Phase Water 13.45 40.35 A 50%H₂O₂ 4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A Na Edatate 0.3 0.9 AKNO₃ 2 6 A Glycerin 18.5 55.5 A2 carbamide peroxide 6 18 A2 Antifoamingagent QS QS A2 Klucel GF 39 117 B Propylene Glycol 8.3 24.9 B Polawax NF1.25 3.75 B Combine A & B in “Kitchenaide” C Cabosil EH-5 6 18 C NaturalMint 0.5 1.5 C 100 300

Second Component, Composition 12 % Grams Phase Water 12.95 38.85 A 50%H₂O₂ 4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A Na Edatate 0.3 0.9 AKNO₃ 2 6 A Glycerin 19 57 A2 carbamide peroxide 6 18 A2 Antifoamingagent QS QS A2 Klucel GF 39 117 B Propylene Glycol 8.3 24.9 B Polawax NF1.25 3.75 B Combine A & B in C “Kitchenaide” Cabosil EH-5 6 18 C NaturalMint 0.5 1.5 C 100 300

Second Component, Composition 13 % Grams Phase Water 13.25 39.75 A 50%H₂O₂ 4.2 12.6 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₂ 2 6 A Glycerin19 57 A2 carbamide peroxide 6 18 A2 Antifoaming agent QS QS A2 Klucel GF39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A &B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 50% KOHQS QS C 100 300

Second Component, Composition 14 % Grams Phase Water 15.05 45.15 A 50%H₂O₂ 8.4 25.2 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin19 57 A2 carbamide peroxide 0 0 A2 Antifoaming agent QS QS A2 Klucel GF39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A &B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 50% KOHQS QS C 100 300

Second Component, Composition 15 % Grams Phase Water 10.25 30.75 A 50%H₂O₂ 10.1 30.3 A 10% KOH QS A Ca(NO₃)₂ 0.5 1.5 KNO₃ 2 6 Glycerin 14 42A2 carbamide peroxide 8.1 24.3 A2 Antifoaming agent QS QS A2 Klucel GF39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A &B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 16 % Grams Phase Water 10.25 30.75 A 50%H₂O₂ 10.1 30.3 A 10% KOH QS A Ca(NO₃)₂ 0.5 1.5 KNO₃ 2 6 Glycerin 14 42A2 carbamide peroxide 8.1 24.3 A2 Antifoaming agent QS QS A2 Klucel GF39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A &B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 17 % Grams Phase Water 13.75 41.25 A 50%H₂O₂ 3.6 10.8 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin20 60 A2 carbamide peroxide 5.1 15.3 A2 Antifoaming agent QS QS A2Klucel GF 39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 BCombine A & B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.51.5 C 100 300

Second Component, Composition 18 % Grams Phase Water 13.5 40.5 A 50%H₂O₂ 3.85 11.55 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin19.6 58.8 A2 carbamide peroxide 5.5 16.5 A2 Antifoaming agent QS QS A2Klucel GF 39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 BCombine A & B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.51.5 C 100 300

Second Component, Composition 19 % Grams Phase Water 10.25 30.75 A 50%H₂O₂ 5.3 15.9 A 10% KOH QS A Ca(NO₃)₂ 0.5 1.5 KNO₃ 2 6 Glycerin 12.336.9 A2 carbamide peroxide 14.6 43.8 A2 Antifoaming agent QS QS A2Klucel GF 39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 BCombine A & B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.51.5 C 100 300

Second Component, Composition 20 % Grams Phase Water 5 15 A 50% H₂O₂11.8 35.4 A 10% KOH QS A Ca(NO₃)₂ 0.5 1.5 KNO₃ 2 6 Glycerin 9.45 28.35A2 carbamide peroxide 16.2 48.6 A2 Antifoaming agent QS QS A2 Klucel GF39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A &B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 21 % Grams Phase Water 13.5 40.5 A 50%H₂O₂ 3.85 11.55 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin19.6 58.8 A2 carbamide peroxide 5.5 16.5 A2 Antifoaming agent QS QS A2Klucel GF 39 117 B Propylene Glycol 8.3 24.9 B Crodaphos 1.25 3.75 BCombine A & B in C “Kitchenaide” Cabosil EH-5 6 18 C Natural Mint 0.51.5 C 100 300

Second Component, Composition 22 % Grams Phase Water 10.25 30.75 A 50%H₂O₂ 10.1 30.3 A 10% KOH QS A Ca(NO₃)₂ 0.5 1.5 KNO₃ 2 6 Glycerin 14 42A2 carbamide peroxide 8.1 24.3 A2 Antifoaming agent QS QS A2 Klucel GF39 117 B Propylene Glycol 8.3 24.9 B Crodaphos 1.25 3.75 B Combine A & Bin “Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 23 % Grams Phase Water 13.25 39.75 A 50%H₂O₂ 3.3 9.9 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 2 6 A Glycerin20.4 61.2 A2 carbamide peroxide 5.5 16.5 A2 Antifoaming agent QS QS A2Klucel GF 39 117 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 BCombine A & B in “Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint 0.51.5 C 100 300

Second Component, Composition 24 % Grams Phase Water 13.25 39.75 A 50%H₂O₂ 3.3 9.9 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 0 0 A Glycerin21.4 64.2 A2 carbamide peroxide 5.5 16.5 A2 Antifoaming agent QS QS A2Klucel GF 40 120 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 BCombine A & B in “Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint 0.51.5 C 100 300

Second Component, Composition 25 % Grams Phase Water 13.75 41.25 A 50%H₂O₂ 3.6 10.8 A 10% KOH QS QS A Ca(NO₃)₂ 0.5 1.5 A KNO₃ 0 0 A Glycerin21 63 A2 carbamide peroxide 5.1 15.3 A2 Antifoaming agent QS QS A2Klucel GF 40 120 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 BCombine A & B in “Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint 0.51.5 C 100 300

Second Component, Composition 26 % Grams Phase Water 10.25 30.75 A 50%H₂O₂ 10.1 30.3 A 10% KOH QS A Ca(NO₃)₂ 0.5 1.5 KNO₃ 0 0 Glycerin 15 45A2 carbamide peroxide 8.1 24.3 A2 Antifoaming agent QS QS A2 Klucel GF40 120 B Propylene Glycol 8.3 24.9 B Polawax NF 1.25 3.75 B Combine A &B in “Kitchenaide” C Cabosil EH-5 6 18 C Natural Mint 0.5 1.5 C 100 300

Second Component, Composition 27 % Grams Phase 50% Hydrogen peroxide3.62 10.86 A 50% KOH QS QS A CaCO₃ 0.2 0.6 A Glycerin 20 60 A2 carbamideperoxide 17 51 A2 Antifoaming agent QS QS A2 Klucel GF 35 105 BPropylene Glycol 12.68 38.04 B Polawax NF 6.5 19.5 B Combine A & B in“Kitchenaide” C Cabosil EH-5 4.5 13.5 C Natural Mint 0.5 1.5 C 100 300

To summarize, the range of ingredients in the second component in theabove examples are as follows:

-   -   a 50% hydrogen peroxide solution is, fro example, from about 2%        to about 15%, more for example, from about 4% to about 12%;        carbamide peroxide is, for example, from about 3% to about 15%,        more for example, from about 5% to about 12.0%; aerosol, such as        Cabosil EH-5, is, for example, from about 2% to about 10%, more        for example, about 4% to about 6%, and lower ranges are present        for foamable or foamed compositions; glycerin is, for example,        from about 5% to about 25%, more for example, from about 9% to        about 22%; gelling agent such as Klucel GF is, for example, from        about 25% to about 50%, more for example, from about 30% to        about 45%, Polawax NF is, for example, from about 1% to about        10%, more for example, from about 1% to about 7%; and propylene        glycol is, for example, from about 5% to about 15%, more for        example, from about 7% to about 13%. Other ranges may be sued        without detracting from the present invention.

The foam made with any of the above compositions are very long lasting,for example, more than 8 hours, when the amounts of gelling agents andsimilar ingredients remained the same as shown in the above examples.For some of the compositions of the second component, the foam formedwas not as stiff as the foam formed with some of the first componentcompositions due to the lower viscosities of these second components.

Having described the invention with reference to accompanyingillustrations and examples of the invention, it is contemplated thatother changes can be made without departing from the spirit or scope ofthe invention as set forth in the appended claims.

1-37. (canceled)
 38. A light-activatable 2-component dental whiteningsystem comprising: a first component comprising at least one peroxidecompound, at least one source of phosphate and at least one gellingagent; and a second component comprising at least one source of calcium,strontium or mixtures thereof, and at least one gelling agent; whereinsaid peroxide compound decomposes in the presence of light.
 39. Thelight-activatable 2-component dental whitening system of claim 38wherein said second component comprises at least one peroxide compound.40. The light-activatable 2-component dental whitening system of claim38 wherein said second component further comprises an ingredientselected from a group consisting of a de-sensitizing agent, anantibacterial agent, a fluoridating agent, a vitamin supplement, ananti-staining agent, an anti-plaque agent and mixtures thereof.
 41. Thelight-activatable 2-component dental whitening system of claim 38wherein the source of phosphate in the first component is selected fromthe group consisting of monosodium phosphate (NaH₂PO₄), disodiumphosphate, tetrapotassium pyrophosphate and mixtures thereof
 42. Thelight-activatable 2-component dental whitening system of claim 41wherein said source of phosphate is adapted to adjust the pH value ofthe dental whitening system.
 43. The light-activatable 2-componentdental whitening system of claim 42 wherein the pH value of the systemis about 5 to about
 8. 44. The light-activatable 2-component dentalwhitening system of claim 42 wherein the pH value of the system is about5.5 to about 6.5.
 45. The light-activatable 2-component dental whiteningsystem of claim 38 wherein the system is foamable.